Global Development Scientist, Director

Global Development Scientist, Director

Gaithersburg, MD

Introduction to role:
Are you ready to steer global hematology trials that turn bold science into life-changing medicines? As Global Development Scientist, Director, you will shape the clinical evidence that moves transformative therapies from hypothesis to registration and into the hands of physicians and patients who need them most.

You will join a global, cross-functional team pushing the boundaries of cancer research, leveraging multiple scientific platforms including immuno-oncology, tumor drivers and resistance, DNA damage response, antibody-drug conjugates, cell therapy and epigenetic approaches. Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate promising assets across early and late development, and help define standards of care. Can you see yourself leading pivotal protocols and turning complex data into clear, compelling conclusions for regulators and the medical community?

Accountabilities:

• Clinical Strategy Translation:
  Convert disease strategy and target product profiles into study concepts, protocols and key study documents in partnership with the Clinical Project Team and Global Study Team.
• Protocol Leadership and Governance:
  Provide the clinical and scientific leadership and integrity for protocols and clinical plans; own the final protocol and governance approvals, ensuring alignment with GCP, ICH and AstraZeneca quality standards.
• Trial Design and Delivery:
  Provide clinical/scientific input into early and late phase trials, including studies involving immunotherapy and cell therapy; partner with Clinical Operations to plan, recruit and deliver at pace, ensuring high-quality execution.
• Data Integrity and Interpretation:
  Lead clinical data review and medical data cleaning; synthesize efficacy and safety signals with the Global Development Medical Director; draw clear conclusions that inform go/no-go decisions and publications; deliver high-quality clinical study reports on time.
• Regulatory Evidence and Submissions:
  Prepare and contribute clinical content for global submissions (e.g., NDA/BLA) and lifecycle documents including Investigator's Brochure, DSUR, PSUR and regulatory responses to enable worldwide registration.
• Stakeholder
  
  Collaboration:
  
  Build strong internal networks across clinical, operations and quality, and form effective relationships with regulatory bodies and external service providers to maintain momentum and resolve issues quickly.
• Site and Investigator Engagement:
  Provide timely responses to investigational sites on ICF changes and protocol questions; plan and deliver effective investigator meetings and training to drive consistency and quality.
• Cross-Program Leadership and Improvement:
  Lead or contribute to cross-asset or cross-tumor initiatives, evaluate new opportunities and externally sponsored research, and drive process improvements that raise performance across the portfolio.
• Ethical and Compliance Leadership:
  Operate to the highest ethical standards in accordance with internal SOPs, local regulations and Good Clinical Practice.

Essential Skills/

Experience:

• BS required;
  PhD in a scientific field, PharmD or MD is strongly preferred
• Minimum of 5 years of relevant experience
• Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred
• Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partner
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Possesses general knowledge of
  1) medical monitoring
  2) Regulatory approval process in relevant countries;
  3) pharmaceutical industry/R&D operations;
  4) marketing and commercial fundamentals
• Drug Development/Clinical Development Planning:
  Demonstrates a consistent track record to both independently complete, and lead peers in completion in components of sophisticated plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools
• Ability to drive/contribute to protocol design, writing and implementation

Desirable Skills/

Experience:

• Experience contributing to or leading clinical components of NDA/BLA submissions and interactions with regulatory authorities
• Hands-on experience with immunotherapy, cell therapy and combination trial design in haematologic malignancies
• Proven leadership of cross-functional initiatives and process improvement projects across assets or tumor areas
• Track record of collaboration with external service providers and oversight of global studies across regions
• Experience planning and delivering investigator meetings and training; strong communication that influences diverse stakeholders
• More than 7–10 years of total clinical development experience is a plus

When we put unexpected teams in the same room, we unleash bold…